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Fixation of Comminuted Distal Radius Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04798846
Recruitment Status : Not yet recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Eslam Abdelnaby Abdelsabor, Sohag University

Study Description
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Brief Summary:
comparison between different methods in fixation of comminuted distal radius fractures

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Procedure: dorsal plating Not Applicable

Detailed Description:

This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture.

The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion .

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: External fixator
patient treated by external fixator
 Procedure: dorsal plating
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Other Name: External fixator
Active Comparator: Dorsal plate
patient treated by dorsal spanning plate
 Procedure: dorsal plating
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Other Name: External fixator


Outcome Measures
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Primary Outcome Measures :
  1. Mayo modified wrist score [ Time Frame: up to 6 month ]
    measure.grip strength


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

  • Inclusion criteria

    • Skeletally mature patients aging 18 or more
    • Comminuted distal radius fractures Fernandez type V

  • Exclusion criteria

    • Age less than 18 year or more
    • Patients with previous fracture affecting wrist joint in the same side.
    • Parients with active infection in the affected joint
    • Pathological fracture
    • Neurological disorder (epilepsy…etc) Reheumatoid
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Eslam Abdelnaby Abdelsabor, principal investigator, Sohag University
ClinicalTrials.gov Identifier: NCT04798846    
Other Study ID Numbers: Soh_Med_21_02_11
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eslam Abdelnaby Abdelsabor, Sohag University:
distal radius fracture
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries